BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    PACS

    Reg #: 3003941243 · FEI: 3003941243 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDICAL STANDARD CO., LTD.
    Registration Number
    3003941243
    FEI Number
    3003941243
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    701 MK Tower, 67, Jeongui-ro
    City
    Songpa-gu Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K042311

    Owner / Operator

    Firm Name
    MEDICAL STANDARD CO., LTD.
    Operator Number
    9053371
    Address
    701 MK Tower, 67, Jeongui-ro
    City
    Songpa-gu
    State
    Seoul
    Postal Code
    05835
    Country
    KR
    Correspondent
    Hyunji Ko

    US Agent

    Business Name
    KMC USA, Inc
    Contact Name
    SEOK WOO KIM
    Address
    5450 ASTOR LANE #203, Suite 700
    City
    Rolling Mdws
    State
    IL
    ZIP
    60008
    Country
    US
    Email
    [email protected]
    Phone
    847 9241545

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    PACS

    Establishment Types

    Manufacture Medical Device